About the PPLA
The Pharmaceutical Printed Literature Association (PPLA) is a trade group representing printers of regulated pharmaceutical information, including Package Inserts (PIs), Medication Guides (MedGuides), and Patient Package Inserts (PPIs) as well as other label packaging such as folding cartons and pressure-sensitive labels. Material and technology suppliers are also part of the PPLA.
The industry is specialized:
- Package Inserts accompany drugs manufactured under the strict guidelines of the FDA. Because Labeling Content, the term used for what the Package Insert covers, is so tightly controlled, pharmaceutical printers also operate according to the principles and practices of current Good Manufacturing Practices (cGMP).
- The miniature folding equipment for Package Inserts is designed to produce folded package inserts specifically for the pharmaceutical market, not for a broad array of markets for printing.
Chartered in 2001, the PPLA serves as the voice for our members, advocating for patient safety and risk communication by fighting to keep information on paper and readily accessible for patients and caregivers. This information helps drive the patient involvement model of health care, helping patients get the maximum benefits from the powerful drugs they take while minimizing risk.
The PPLA Position
The PPLA advocates to legislative, regulatory and other decision-making bodies for the continued use of printed literature. With regular Capitol Hill day visits with senators and congressman, the PPLA stays in close communication with the legislative branch. We testify at public hearings and provide information to strategic partners and the public.
The PPLA does not oppose making Labeling Content for Package Inserts, Medication Guides and Patient Package Inserts available electronically, particularly since it is already available in that format. What we do oppose is making the information available ONLY electronically and eliminating paper because:
- Electronic information is not available to everyone
- Sometimes electronic information is not available to anyone (power outages, natural or manmade disasters)
- Patients prefer information on paper, and comprehend that information better
- The law requires paper information that is manufacturer supplied and FDA approved